Pentas granules of prolonged action for oral administration 1g sachets 50 pcs. (mesalazane)

Latin name

PENTASA

Release form

Granules for prolonged oral administration are cylindrical, from light gray to light brown in color.

Pharmacological action

Mesalazine - 5-aminosalicylic acid - is the active component of sulfasalazine.

Pentasa® granules are mesalazine microbeads coated with an ethyl cellulose coating. The therapeutic effect of mesalazine after oral administration is more due to the local effect on the inflamed intestinal tissue than the systemic effect.

The therapeutic effect of mesalazine is manifested by local contact with the affected intestinal mucosa.

Mesalazine inhibits leukocyte chemotaxis, reduces the production of cytokines and leukotriene, and also reduces the formation of free radicals in inflamed intestinal tissue. But the exact mechanism of action of mesalazine is not fully understood.

Indications

• Ulcerative colitis

• Crohn’s disease

Contraindications

• Hypersensitivity to salicylates and other components of the

preparation • Severe hepatic or renal failure

• Peptic ulcer or duodenal ulcer

• Hemorrhagic diathesis of

from 6 years old the drug must consult a doctor.

With caution:

With caution, the drug should be prescribed to patients with impaired lung function, in particular, with bronchial asthma.

Caution should be exercised when prescribing PentasaВ® to patients with mild to moderate renal / hepatic insufficiency, since a decrease in elimination rate and an increase in systemic concentration of mesalazine increases the risk of kidney damage.

Special instructions

In case of acute symptoms of intolerance to the drug (muscle cramps, abdominal pain, fever, severe headache and skin rashes) or signs of impaired liver and / or kidney function, PentasaВ® should be discontinued.

During the entire course of treatment with PentasaВ®, blood creatinine concentration should be regularly monitored.

Composition

1 pack. - mesalazine 1000 mg.

Excipients: ethyl cellulose - 4 mg - 15 mg, povidone - 50 mg.

Dosage and administration

Granules are recommended to be taken after a meal without chewing. Pour the contents of one sachet onto the tongue and drink it with water or juice.

Children over 6 years of age and adolescents: dosage is selected individually. The recommended dose during exacerbation is 20-30 mg of mesalazine per kilogram of body weight per day in several doses, the maximum single dose is not more than 75 mg / kg, the maximum daily dose is not more than 4 g. The recommended maintenance dose is 20-30 mg / kg / day, the maximum daily dose of not more than 2 g. Children with a body weight of more than 40 kg are recommended to prescribe doses for adults.

Adults: dosage is selected individually. The recommended dose in the period of exacerbation up to 4 g per day, divided into several doses, maintenance therapy 2 to 4 g per day, divided into several doses.

The duration of therapy is determined by the attending physician.

Drug Interactions

With the simultaneous administration of the drug Pentasa with azathioprine or 6-mercaptopurine, the risk of suppressing bone marrow function (leukopenia, thrombocytopenia, erythrocytopenia / anemia, or pancytopenia) is increased. The simultaneous administration of Pentasa® and other drugs with nephrotoxicity, for example, non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, increases the risk of adverse reactions from the kidneys.

Slows down the absorption of cyanocobalamin (vitamin B12), enhances the hypoglycemic effect of sulfonylurea derivatives, ulcerogenicity of glucocorticosteroids, toxicity of methotrexate, weakens the activity of furosemide, spironolactone, sulfanilamides, rifampicin, probenecid and sulfinoseuricin antioxidants, enhances the efficacy of anti-inflammatory drugs, and enhances the efficacy of anti-inflammatory drugs. With the simultaneous use of mesalazine and digoxin preparations, the absorption of digoxin decreases.

Overdose

Pentas® overdose is rare. There are no specific antidotes. It is recommended to wash the stomach and take steps to increase diuresis. In case of acidosis, alkalosis, dehydration, hyperventilation or pulmonary edema, acid-base and water-electrolyte balance must be restored. At signs of hypoglycemia it is necessary to accept glucose.

Storage Conditions

At a temperature not exceeding 25 ° C.

Keep out of the reach and sight of children.

Shelf life

2 years.

Do not use after expiration date.

Terms and conditions

prescription

Dosage form

tablets prolong.

Possible product names

Oral pentagol 50 pills PCS.



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